2.5 mg and 5 mg tablets 
Bendroflumethiazide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bendroflumethiazide Alternova is and what it is used for 
2. What you need to know before you use Bendroflumethiazide Alternova 
3. How to use Bendroflumethiazide Alternova 
4. Possible side effects 
5. How to store Bendroflumethiazide Alternova 6. Contents of the pack 
and other information 

What Bendroflumethiazide Alternova is and what it is used for

Bendroflumethiazide Alternova belongs to a group of medicines called thiazides.

Bendroflumethiazide Alternova is used to treat:

  • High blood pressure
  • Swelling ( edema )
  • Preventive treatment for kidney stones

Bendroflumethiazide Alternova´’s blood pressure lowering effect is probably due to the dilation of certain small blood vessels. The diuretic effect is due to the influence of the kidney which causes fluid to leave the body.

Bendroflumethiazide Alternova in some cases prevents the formation of kidney stones by reducing the calcium content in the urine.

Bendroflumethiazide contained in Bendroflumethiazide Alternova may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Bendroflumethiazide Alternova

Do not use Bendroflumethiazide Alternova

  • If you are allergic (hypersensitive) to Bendroflumethiazide or any of the other ingredients of this medicine (listed in section 6)
  • In severe liver and kidney diseases
  • Gout
  • Hypersensitivity thiazide s
  • Hypersensitivity to sulfonamides

Warnings and cautions

Talk to your doctor or pharmacist before using this medicine if you have any of the following:

  • If you are diabetic
  • If you have tried thiazides or thiazide-like preparations and then reacted to them
  • Concomitant treatment with digitalis (heart-strengthening medicines)
  • If you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Bendroflumethiazide Alternova. If left untreated, it can lead to permanent vision loss. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.

Children and young people

Bendroflumethiazide Alternova is not recommended for use in children and adolescents.

Other medicines and Bendroflumethiazide Alternova

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The treatment effect may be affected if Bendroflumethiazide Alternova and certain other medicines are taken at the same time.

Therefore, treating physicians need to be aware of such concomitant use of certain drugs:

  • against high blood fats such as cholestyramine and colestipol (these medicines may reduce the uptake of thiazide diuretics, they should therefore be given at intervals of several hours after taking Bendroflumethiazide Alternova)
  • heart-strengthening medicines ( digitalis glycosides, sotalol)
  • certain antihypertensive agents ( ACE inhibitors )
  • a group of painkillers, anti-inflammatory and antipyretic drugs called NSAIDs non-steroidal anti-inflammatory / anti-rheumatic drugs such as indomethacin
  • lithium.

Bendroflumethiazide Alternova with food and drink

Bendroflumethiazide Alternova can be taken with food and drink. The tablets should be taken with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Bendroflumethiazide Alternova during pregnancy.

Breast-feeding

It is not known if Bendroflumethiazide Alternova passes into breast milk. Therefore, consult a physician before regular use during breast-feeding.

Fertility

There are no data available on fertility.

Driving and using machines

Temporary dizziness may occur during blood pressure treatment, which should be taken into account when driving or maintaining machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist

Bendroflumethiazide Alternova contains lactose

Bendroflumethiazide Alternova contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Bendroflumethiazide Alternova

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults:

The recommended dose is:

Dose one is determined by the doctor, who adjusts it individually for you. A common dose range is 2.5 mg – 10 mg per day.

The recommended dose for:

High blood pressure: 2.5 mg – 5 mg in the morning.

Swelling ( edema ): 2.5 mg – 10 mg in the morning.

Premenstrual swelling: 2.5 mg for 7-10 days before menstruation.

Kidney stone disease: 2.5 mg morning and evening.

If you forget to use Bendroflumethiazide Alternova

Do not take a double dose to make up for a forgotten tablet.

If you stop using Bendroflumethiazide Alternova

Do not stop taking Bendroflumethiazide Alternova unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following description of how common the side effects are has been used:

Common (affects more than 1 user in 100):

At the beginning of treatment, dizziness and headaches may occur but are transient. Blood sugar levels can be affected in diabetics or people with a predisposition to diabetes. Uric acid levels in the blood can become too high and cause gout problems.

Uncommon (affects less than 1 user in 100):

Drop-in blood pressure in a standing position (usually affects the elderly and causes dizziness or fainting). Increased urinary excretion of magnesium and increased levels of calcium in the blood. Decreased level of sodium in the blood. Increased light sensitivity.

Rare (affects less than 1 user in 1,000):

Itching, rash, vascular inflammation, decreased platelet count, or a decrease in white blood cell count. These reactions usually stop when the medication is stopped. Disorders in acid-base balance one.

Has been reported :

Acute myopia, secondary narrow-angle glaucoma, impaired vision, or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina)).

Isolated cases of impotence have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Bendroflumethiazide Alternova

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after “Ed. Dat .: ”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Bendroflumethiazide Alternova 2.5 mg tablets:

  • The active substance is bendroflumethiazide 2.5 mg
  • Other ingredients are:

Anhydrous lactose

Pregelatinized corn starch

Stearic acid

Talc

Bendroflumethiazide Alternova 5 mg tablets:

  • The active substance is bendroflumethiazide 5 mg
  • Other ingredients are:

Anhydrous lactose

Pregelatinized corn starch

Stearic acid

Talc

What the medicine looks like and the contents of the pack

Bendroflumethiazide Alternova 2.5 mg tablets: Round, flat, white to off-white biconvex tablets and approximately 5.5 mm in diameter.

Bendroflumethiazide Alternova 5 mg tablets: Round, flat, white to off-white tablets with beveled edges, marked with “5” on one side and a diameter of about 7 mm.

Blister: 98 tablets.

Plastic jar of HDPE and HDPE / PP lids: 100, 105, 200, 250, 300 and 500 tablets

Possibly all pack sizes will be marketed.

Marketing Authorisation Holder

Alternova A / S

Lodshusvej 11

4230 Skælskør

Denmark

Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Muhammad Nadeem

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